Section 100 – Highly Specialised Drugs Program

Page last updated: 1 September 2019

The Highly Specialised Drugs (HSD) Program provides access to specialised Pharmaceutical Benefits Scheme (PBS) medicines for the treatment of chronic conditions which, because of their clinical use and other special features, have restrictions on where they can be prescribed and supplied.  In most cases, medical practitioners are required to undertake specific training or be affiliated with a specialised hospital unit to prescribe these medicines.

The National Health (Highly specialised drugs program) Special Arrangement 2010 provides the legislative framework for the HSD program.

To gain access to HSDs, a patient must:

  • be an Australian resident and eligible for a Medicare card;
  • attend a participating hospital and be a day admitted patient, a non-admitted patient or a patient on discharge; and
  • be under appropriate specialist medical care and meet specific medical criteria. 

An eligible medical practitioner in a public or private hospital may prescribe HSDs.  In addition, Clozapine for the treatment of schizophrenia (maintenance therapy only), HIV antiretroviral and hepatitis B medicines may be prescribed by authorised community based practitioners.

PBS patient co-payments apply.  Benefits are available for the listed clinical indications only and there is no facility for individual patient approval for indications outside those listed.  Commonwealth subsidy is not available for hospital in-patients.

Where a patient is entitled to be treated as an eligible person as a visitor from a country with which Australia has entered into a Reciprocal Health Care Agreement, the supply will be limited to the original prescription only.  Repeat prescriptions for subsidised HSDs for these patients are not permitted.

Private Hospitals

For HSDs prescribed through private hospitals, claiming and approval of authority prescriptions is administered by Department of Human Services (DHS). Medical practitioners must seek approval to prescribe Authority required items as pharmaceutical benefits prior to their prescribing under the PBS.  Approval of authority prescriptions by DHS may be obtained either by posting an Authority Prescription Form to Department of Human Services, or by using DHS Authority free-call service (1800 888 333), or by using the appropriate Streamlined code. Prescribers must quote the provider number of the hospital when applying.  Maximum quantities and repeats for HSDs are listed in the Schedule. 

Private hospital prescriptions for HSDs can be dispensed by s94 approved private hospital authorities or by s90 approved pharmacists.  Not more than two months’ supply (one month’s supply in the case of Clozapine), with provision for up to 5 repeats or one month and 11 repeats – up to 12 months’ supply, will be authorised.

The remuneration rates for Highly Specialised Drugs prescribed through private hospitals comprise the normal PBS ready-prepared dispensing fee plus a mark-up ascertained as follows:

  • 10% for drugs with a price ex-manufacturer of less than $40;
  • $4 for drugs with a price ex-manufacturer of between $40 and $100;
  • 4% for drugs with a price ex-manufacturer of between $100.01 and $1000;
  • $40 for drugs with a price ex-manufacturer of greater than $1000.

Public Hospitals

For HSDs prescribed through public hospitals, claiming and approval of authority prescriptions is administered by the Department of Human Services (DHS).  HSDs prescribed through public hospitals, except Complex Authority Required (CAR) medicines, are Authority required (Streamlined) items.  Authority approvals are required for prescriptions where the dose is above the determined maximum quantity and/or number of repeats.

Public hospital prescriptions for HSDs can be dispensed by s94 approved public hospital authorities and s90 approved pharmacists through agency arrangements. Not more than two months’ supply (one month’s supply in the case of Clozapine), with provision for up to 5 repeats or one month and 11 repeats – up to 12 months’ supply, will be authorised.

The dispensed price for the supply of HSDs by a hospital authority for a public hospital is the sum of the approved ex‑manufacturer price or the proportional ex‑manufacturer price for each pack quantity.

Complex Authority Required (CAR) medicines

CAR medicines require written authority applications. Subsequent treatment phases may have lower authority requirements (telephone or Authority Required (Streamlined)) however the medicine remains CAR. Approval of authority prescriptions may be obtained by either posting an Authority Prescription form to DHS, using the DHS free-call service for PBS Complex Drugs Programs enquiries (1800 700 270), or using the appropriate Streamlined code for the prescribing setting. Prescribers must quote the provider number of the hospital when applying. Maximum quantities and repeats for HSDs are listed in the Schedule. 

Public hospital prescriptions for CAR medicines can be dispensed by approved s94 public hospital authorities or by s90 approved pharmacists

Community Access

The HSD community access arrangements introduced 1 July 2015 better aligned existing HSD program arrangements with current clinical practice.  These arrangements allow authorised community based practitioners to prescribe clozapine for the treatment of schizophrenia (maintenance therapy only), HIV antiretroviral and hepatitis B medicines without the need to be affiliated with a hospital.  Patients also have greater choice about where they access their medicines, through either a community pharmacy, or a private or public hospital pharmacy.  Community pharmacists are able to dispense these medicines regardless of where the medicine is prescribed.

Not more than two months’ supply (one month’s supply in the case of Clozapine), with provision for up to 5 repeats or one month and 11 repeats – up to 12 months’ supply, will be authorised.

The remuneration rates for HSDs through community pharmacies are as follows:

  • 10% for drugs with a price ex-manufacturer of less than $40;
  • $4 for drugs with a price ex-manufacturer of between $40 and $100;
  • 4% for drugs with a price ex-manufacturer of between $100.01 and $1000;
  • $40 for drugs with a price ex-manufacturer of greater than $1000.